You are here

Generic Version of Zonegran Passes FDA Muster

PITTSBURGH, Dec. 23 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zonisamide Capsules, 25 mg, 50 mg, and 100 mg. Zonisamide Capsules are the AB-rated generic equivalent of Dainippon Pharmaceutical's Zonegran(R) Capsules, which had U.S. sales of approximately $171 million for the 12-month period ending June 30, 2005, according to IMS Health.

This product will begin shipping immediately.

Source: The Food and Drug Administration

Recent Headlines

Teplizumab Slows Progression to Disease by at Least Two 2 Years
Over Half of Patients Had Reduced Pain Levels of 30% or More
Spina Bifida, Cleft Lip Among Defects Caused by Antiepilectics
Study Data Indicate Drug May Provide Complete Remission in PV
Over 25% of Study Patients Showed 6–12 Months Remission
Researchers Extend Previous Data, Find Association is Reversed
First Anti-PD-1 Therapy Demonstrates Improved Overall Survival
New Test Could Prevent Short- and Long-term Complications